CHMP grants accelerated assessment for Daratumumab for double refractory multiple myeloma
Genmab A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorization Application (MAA) for daratumumab. The MAA is for daratumumab as a treatment for patients with relapsed and refractory multiple myeloma. The MAA was submitted to the EMA by Janssen-Cilag International NV. In 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
The CHMP grants accelerated assessment when a medicinal product is expected to be of major public health interest particularly from the point of view of therapeutic innovation.
“Patients with multiple myeloma, particularly those who have exhausted all approved treatment options, are waiting for new medicines to treat this incurable disease. An accelerated approval optimizes the potential for daratumumab to provide a new therapy for this patient group more rapidly than under a standard review time,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The MAA submission includes data from the Phase II study (Sirius MMY2002) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD. Safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies have also been included in the submission. A regulatory application for daratumumab has also been submitted to the U.S. Food and Drug Administration and has been granted Priority Review with a PDUFA date of March 9, 2016.
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